The FDA uses technical advisory committees of outside scientific experts to advise it on the approvability of specific products and on the scientific and clinical policy issues it confronts regarding product development and evaluation. The agency also uses these committees to legitimate the soundness of its analysis of a given product, as a public forum for discussion of controversial issues, and, on occasion, as an "appeals court" for disputed agency decisions.^*

This chapter recounts the history of FDA advisory committees as it has evolved along somewhat different pathways for drugs, biologics, and medical devices. Variations are due partly to the differences in regulatory responsibilities in these areas and partly to the administrative entities and their cultures. At the end of the chapter, a brief section contrasts FDA advisory committees with the study sections of the National Institutes of Health.

The FDA initiated the use of advisory committees in the 1960s and 1970s for the evaluation of drugs. It extended their use in the early 1970s to the review of biologics soon after the Division of Biological Sciences of the National Institutes of Health was transferred to the FDA as the Bureau of Biologics. Finally, following the Cooper report of 1970, FDA in the early 1970s began to use such committees to classify medical devices, a step that Congress later mandated in the Medical Device Amendments of 1976 for both classification and product evaluation purposes.

The FDA's use of agency-chartered advisory committees for drug evaluation has evolved over the three decades since the 1962^** drug amendments to the Food, Drug, and Cosmetic Act. Those amendments required FDA to assess all new drugs for effectiveness, in addition to safety (as required by the 1938 amendments), and to reassess for effectiveness